The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus

The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.

Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.

Study Overview

• Status: Terminated
• Conditions: Humeral Fracture
• Intervention / Treatment: Procedure: Immediate mobilisation after locking-plate osteosynthesis; Device: Osteosynthesis with a locking plate (Philos); Procedure: Standard mobilisation after locking plate osteosynthesis

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Töölö Hospital, Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Surgery can be performed within 10 days of injury
• A dislocated (>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus

Exclusion Criteria:

• Glenohumeral dislocation
• Fracture of the Tuberculum Minus
• Open fracture
• Additional fractures in the shoulder region
• Other injuries requiring surgical treatment
• Clinically significant injury of the brachial plexus or vasculature
• Pathological fracture associated with cancer
• History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
• Rheumatoid Arthritis in the shoulder requiring active treatment
• Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
• Unwillingness to accept some of the treatment options.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate mobilisation	Procedure: Immediate mobilisation after locking-plate osteosynthesis; Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.; Device: Osteosynthesis with a locking plate (Philos); Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.
Active Comparator: Standard mobilisation	Device: Osteosynthesis with a locking plate (Philos); Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.; Procedure: Standard mobilisation after locking plate osteosynthesis; Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	3 weeks
Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	6 weeks
Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	3 months
Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	6 months
Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	1 year
Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Score	subjective and objective shoulder score	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Simple Shoulder Test (SST)	another shoulder score	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pain in rest and motion (2 different values)	Numeric rating scale 0-10	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Subjective satisfaction	Patient reported, Numeric Rating Scale 0-10	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Quality of Life	Using the 15D instrument	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Complications	Complications of surgery and postoperative phase	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Finnish Institute for Health and Welfare
• Investigators: Principal Investigator: Tuomas Lähdeoja, MD, Helsinki University Central Hospital; Study Director: Mika Paavola, MD, PhD, Helsinki University Central Hospital; Study Director: Jarkko Pajarinen, MD, PhD, Helsinki University Central Hospital; Study Chair: Seppo Koskinen, Helsinki University Central Hospital; Study Chair: Antti Malmivaara, MD, PhD, Finnish Institute for Health and Welfare; Study Chair: Reijo Sund, MD, PhD, Finnish Institute for Health and Welfare

Publications and helpful links

General Publications

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): October 21, 2023

Study Registration Dates

• First Submitted: January 22, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimated): February 2, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Physiotherapy; Locking Plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: HUS-272/13/03/02/2010